Back to resultsEvaluation of the Dexmedetomidine Transdermal Systems for Postoperative Analgesia Following Abdominoplasty (DMT2111)
Primary Purpose
Pain, Postoperative
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DMTS Patch
Placebo Patch
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring Abdominoplasty, Pain, Transdermal, DMTS
Eligibility Criteria
Inclusion Criteria:
- Male or female, ≥ 18 years of age.
- Scheduled to undergo a full abdominoplasty (including repair of small incidental abdominal hernias, but not including liposuction).
- Have a physical status classification of 1 or 2 per the American Society of Anesthesiology.
- Have a body weight > 58 kg, and body mass index of 20 to 38 kg/m2, inclusive.
Exclusion Criteria:
- Known sensitivity to dexmedetomidine or any excipient in the DMTS/placebo or to any peri- or postoperative medication whose use is required in this study.
- Skin abnormality (eg, scar, tattoo) or unhealthy skin condition (eg, burns, wounds) at the DMTS/matching placebo application site, according to examination by the investigator at screening or admission to the clinic prior to surgery.
- History of deep vein thrombosis or factor V Leiden deficiency.
- History of syncope or other syncopal attacks.
- Present and/or significant history of postural hypotension (determined through examination by the investigator or designee), or history of severe dizziness or fainting on standing in the opinion of the investigator.
- Evidence of a clinically significant 12-lead ECG abnormality.
Sites / Locations
- Anaheim Clinical Trials, LLCRecruiting
- JBR Clinical ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
DMTS Patch
Placebo Patch
Arm Description
DMTS applied to upper outer arm
Placebo system (with no drug) to match DMTS applied to the upper arm
Outcomes
Primary Outcome Measures
Time-interval weighted summed pain intensity (SPI) at designated time points
The SPI measured using the 11-point (0 to 10) numeric rating scale, where 0 is equal to no pain and 10 is equal to worst pain
Secondary Outcome Measures
Time-interval weighted summed pain intensity (SPI) over various time intervals
The SPI measured using the 11-point (0 to 10) numeric rating scale, where 0 is equal to no pain and 10 is equal to worst pain, measured at rest over various time intervals
Rescue Medication
The proportion of subjects using rescue analgesic medication
Rescue Medication units
Total dose of rescue analgesic medication (in morphine-equivalent units)
Integrated Pain score and Rescue Medication
Integrated assessment of summed pain intensity (SPI) using the 11-point (0 to 10) numeric rating scale, where 0 is equal to no pain and 10 is equal to worst pain, at the time Rescue Medication was administered
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05412992
Brief Title
Evaluation of the Dexmedetomidine Transdermal Systems for Postoperative Analgesia Following Abdominoplasty
Acronym
DMT2111
Official Title
A Double-Blind, Placebo-Controlled Evaluation of the Dexmedetomidine Transdermal Systems for Postoperative Analgesia Following Abdominoplasty
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 6, 2022 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teikoku Pharma USA, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective of this study is to evaluate the analgesic efficacy of DMTS, compared with placebo, in subjects following abdominoplasty.
Detailed Description
This is a randomized, double-blind, placebo-controlled, one-time application study of DMTS or matching placebo over a 4-day treatment period (Day 1 Time 0 occurs when the DMTS or matching placebo systems have been applied). Subjects scheduled for an abdominoplasty will be screened up to 28 days prior to surgery. Eligible subjects will be randomized equally to treatment with DMTS or matching placebo. An independent safety monitoring committee will periodically review unblinded safety data to confirm the safety/tolerability of the dose or recommend a dose reduction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Abdominoplasty, Pain, Transdermal, DMTS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomized in 1:1 ratio to receive DMTS or matching placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The sponsor, the investigator, personnel at the clinical study unit who are directly involved with monitoring and/or performing study procedures and assessments, and the subjects will be blinded to treatment assignment
Allocation
Randomized
Enrollment
182 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DMTS Patch
Arm Type
Active Comparator
Arm Description
DMTS applied to upper outer arm
Arm Title
Placebo Patch
Arm Type
Placebo Comparator
Arm Description
Placebo system (with no drug) to match DMTS applied to the upper arm
Intervention Type
Drug
Intervention Name(s)
DMTS Patch
Other Intervention Name(s)
DMTS
Intervention Description
DMTS applied before surgery and worn for 96 hours
Intervention Type
Drug
Intervention Name(s)
Placebo Patch
Other Intervention Name(s)
Placebo
Intervention Description
Matching patches that have no active drug applied before surgery and worn for 96 hours
Primary Outcome Measure Information:
Title
Time-interval weighted summed pain intensity (SPI) at designated time points
Description
The SPI measured using the 11-point (0 to 10) numeric rating scale, where 0 is equal to no pain and 10 is equal to worst pain
Time Frame
5 to 96 hours following surgery
Secondary Outcome Measure Information:
Title
Time-interval weighted summed pain intensity (SPI) over various time intervals
Description
The SPI measured using the 11-point (0 to 10) numeric rating scale, where 0 is equal to no pain and 10 is equal to worst pain, measured at rest over various time intervals
Time Frame
5 to 96 hours following surgery
Title
Rescue Medication
Description
The proportion of subjects using rescue analgesic medication
Time Frame
Up to 96 hours post surgery
Title
Rescue Medication units
Description
Total dose of rescue analgesic medication (in morphine-equivalent units)
Time Frame
Up to 96 hours post surgery
Title
Integrated Pain score and Rescue Medication
Description
Integrated assessment of summed pain intensity (SPI) using the 11-point (0 to 10) numeric rating scale, where 0 is equal to no pain and 10 is equal to worst pain, at the time Rescue Medication was administered
Time Frame
Up to 96 hours post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female, ≥ 18 years of age.
Scheduled to undergo a full abdominoplasty (including repair of small incidental abdominal hernias, but not including liposuction).
Have a physical status classification of 1 or 2 per the American Society of Anesthesiology.
Have a body weight > 58 kg, and body mass index of 20 to 38 kg/m2, inclusive.
Exclusion Criteria:
Known sensitivity to dexmedetomidine or any excipient in the DMTS/placebo or to any peri- or postoperative medication whose use is required in this study.
Skin abnormality (eg, scar, tattoo) or unhealthy skin condition (eg, burns, wounds) at the DMTS/matching placebo application site, according to examination by the investigator at screening or admission to the clinic prior to surgery.
History of deep vein thrombosis or factor V Leiden deficiency.
History of syncope or other syncopal attacks.
Present and/or significant history of postural hypotension (determined through examination by the investigator or designee), or history of severe dizziness or fainting on standing in the opinion of the investigator.
Evidence of a clinically significant 12-lead ECG abnormality.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James Song, MS, MA
Phone
408-501-1821
Email
jsong@teikokuusa.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Song, MS, MA
Organizational Affiliation
Teikoku Pharma USA, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Anaheim Clinical Trials, LLC
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter J. Winkle, MD
Phone
714-774-7777
Email
p.winkle@cenexel.com
Facility Name
JBR Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Todd Bertoch, MD
Phone
801-261-2000
Email
tbertoch@jbrutah.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan is in place to share individual participant data at this time.
Learn more about this trial
Evaluation of the Dexmedetomidine Transdermal Systems for Postoperative Analgesia Following Abdominoplasty
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